uniQure N.V. — News

uniQure posts a wider Q2 2026 loss as revenues missed estimates, but regulatory progress for AMT-130 and a cash runway into 2030 keep its pipeline in focus.

zacks.com - 2026-07-30 12:01:11

Wall Street analysts reshuffled their bets on Thursday as geopolitical fires, a Fed dissent surprise, and a brutal semiconductor selloff forced some major rating reversals across insurance, gaming, tech, and energy stocks.

247wallst.com - 2026-07-30 08:05:16

uniQure N.V. (QURE) Q2 2026 Earnings Call Transcript

seekingalpha.com - 2026-07-29 14:53:19

uniQure NASDAQ: QURE said it has aligned with the U.S. Food and Drug Administration on a potential accelerated-approval pathway for AMT-130, its investigational gene therapy for Huntington's disease, and remains on track to submit a biologics license application in the third quarter of 2026.

marketbeat.com - 2026-07-29 13:05:39

uniQure (QURE) came out with a quarterly loss of $1.22 per share versus the Zacks Consensus Estimate of a loss of $0.81. This compares to a loss of $0.69 per share a year ago.

zacks.com - 2026-07-29 09:31:08

~ U.S. and U.K. regulatory submissions for AMT-130 for Huntington's disease on track as planned for the third quarter of 2026 ~ ~ Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026 ~ ~ Reported data from the first cohort in the Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy showed early biological signals of therapeutic activity and a favorable safety profile ~ ~ Strengthened financial position with $259 million follow-on offering, extending cash runway into 2030 and funding the anticipated commercial launch of AMT-130 and continued pipeline investment ~ ~ uniQure to host earnings call at 8:30 a.m. ET ~ LEXINGTON, Mass.

globenewswire.com - 2026-07-29 07:05:00

~ uniQure to host earnings call on Wednesday, July 29, 2026 at 8:30 a.m. ET ~ ~ uniQure to host earnings call on Wednesday, July 29, 2026 at 8:30 a.m. ET ~

globenewswire.com - 2026-07-22 07:05:00

QURE is sharpening its gene therapy focus through faster regulatory pathways, a streamlined business model and CNS pipeline expansion, with AMT-130 at the center.

zacks.com - 2026-07-17 15:56:04

QURE has soared on renewed AMT-130 optimism, but rich valuation, uneven earnings and pending regulatory milestones keep the gene therapy story balanced.

zacks.com - 2026-07-17 15:32:03

QURE's AMT-130 is driving investor focus as FDA feedback, a targeted third-quarter 2026 filing and cash into 2029 shape its regulatory outlook.

zacks.com - 2026-07-17 15:26:05

uniQure N.V. (QURE) reached a significant support level, and could be a good pick for investors from a technical perspective.

zacks.com - 2026-07-01 10:55:17

LEXINGTON, Mass. and AMSTERDAM, June 25, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the closing of its previously announced underwritten public offering of 5,686,813 ordinary shares at a public offering price of $45.50 per share, which includes 741,758 ordinary shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional ordinary shares in the offering. The aggregate gross proceeds to uniQure from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by uniQure, were approximately $259 million. All securities in the offering were sold by uniQure.

globenewswire.com - 2026-06-25 16:10:00

LEXINGTON, Mass. and AMSTERDAM, June 23, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the pricing of its previously announced underwritten public offering of 4,945,055 ordinary shares at a public offering price of $45.50 per share. The aggregate gross proceeds to uniQure from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by uniQure, are expected to be approximately $225 million. All securities to be sold in the offering are being sold by uniQure. In addition, uniQure has granted to the underwriters a 30-day option to purchase up to 741,758 additional ordinary shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 25, 2026, subject to the satisfaction of customary closing conditions.

globenewswire.com - 2026-06-23 21:13:00

LEXINGTON, Mass. and AMSTERDAM, June 22, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it has commenced a $150 million underwritten public offering of its ordinary shares and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase its ordinary shares. All securities to be sold in the offering will be offered by uniQure. In addition, uniQure intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its ordinary shares on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

globenewswire.com - 2026-06-22 16:01:00

uniQure reports early AMT-260 epilepsy study data, with three patients showing 79-100% seizure reductions and no serious safety events.

zacks.com - 2026-06-22 11:31:24

QURE surges after the FDA said AMT-130 phase I/II data could support an accelerated approval filing for Huntington's disease.

zacks.com - 2026-06-19 15:20:32

~ AMT-260 was generally well-tolerated with no serious adverse events observed to date, with early biological signals of potential therapeutic activity ~

globenewswire.com - 2026-06-19 07:05:00

QURE is now a more credible Huntington's disease gene-therapy story after the FDA reopened a near-term BLA path for AMT-130. The main bet is that AMT-130 could eventually become the first approved disease-modifying therapy for Huntington's disease. Also, QURE's balance sheet gives management time to pursue that BLA for AMT-130.

seekingalpha.com - 2026-06-18 10:06:55

uniQure (QURE) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

zacks.com - 2026-06-18 08:31:06

uniQure N.V. surges as the FDA now accepts Phase 1/2 data for AMT-130 as the primary basis for accelerated approval in Huntington's disease. QURE plans to submit its BLA for AMT-130 in Q3 2026, with a potential US market launch before year-end if granted priority review. Peak revenue potential for AMT-130 is now estimated (by me) at $1.5bn by 2030, supporting a bullish valuation case and suggesting up to 50% further upside.

seekingalpha.com - 2026-06-17 15:40:38

Biotech stocks climbed Wednesday after the Food and Drug Administration signaled the end of a "nail-biting journey" for UniQure.

investors.com - 2026-06-17 14:12:06

UniQure said it plans to seek approval for its experimental gene therapy for Huntington's disease. The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application.

cnbc.com - 2026-06-17 12:12:05

uniQure (QURE) stock is ripping higher this morning after the biopharmaceutical firm announced a major regulatory breakthrough with the FDA for its Huntington's disease gene therapy AMT-130. As investors cheered the disclosure, QURE pushed past its key moving averages (MAs) – and its relative strength index (RSI) climbed into the mid-80s, indicating intense buying pressure.

invezz.com - 2026-06-17 11:32:28

uniQure N.V. (NASDAQ:QURE) stock is up during Wednesday's premarket session as the company announced plans for a Biologics License Application (BLA) submission for AMT-130, a gene therapy treatment for Huntington's disease.

benzinga.com - 2026-06-17 10:31:44

Gene therapy maker uniQure is one step closer to marketing its treatment for Huntington's disease.

barrons.com - 2026-06-17 10:10:00

Dutch drugmaker ​UniQure said ‌on Wednesday the ​U.S. ​Food and Drug ⁠Administration ​has agreed ​that data from a ​mid-stage ​study could support ‌an ⁠accelerated approval filing for ​its ​gene ⁠therapy to ​treat Huntington's ​disease.

reuters.com - 2026-06-17 07:13:00

~ 3-year analysis from the Phase I/II study can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ~

globenewswire.com - 2026-06-17 07:05:00

uniQure remains highly sensitive to AMT-130's regulatory outcome, with current valuation reflecting significant uncertainty around FDA approval. Recent FDA leadership changes and a scheduled Type B meeting may improve the odds for AMT-130, but a Phase 3 trial is still likely required. My scenario analysis shows QURE's fair value per share ranges from $10.73 (bear) to $77.55 (bull), with the base case at $26.73.

seekingalpha.com - 2026-06-01 11:14:55

UniQure is upgraded from Hold to Buy, driven by near-term UK approval prospects for AMT-130 and a robust cash runway to 2029. Despite FDA requiring a new Phase 3 trial for AMT-130 in Huntington's, a UK submission is imminent, positioning QURE for a major catalyst. QURE's pipeline, including AMT-260 for epilepsy and AMT-191 for Fabry, offers additional upside, though AMT-162 was discontinued.

seekingalpha.com - 2026-05-12 10:24:05

uniQure N.V. (QURE) Q1 2026 Earnings Call Transcript

seekingalpha.com - 2026-05-05 15:41:26

uniQure (QURE) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $0.88. This compares to a loss of $0.82 per share a year ago.

zacks.com - 2026-05-05 09:26:11

~ Advancing FDA interactions on AMT-130 for Huntington's disease; Type B meeting scheduled for the second quarter of 2026 ~

globenewswire.com - 2026-05-05 07:05:00